Generic Zometa Availability

Zometa is a brand name of zoledronic acid, approved by the FDA in the following formulation(s):

ZOMETA (zoledronic acid - injectable;iv (infusion))

  • Manufacturer: NOVARTIS
    Approval date: March 7, 2003
    Strength(s): EQ 4MG BASE/5ML [RLD] [AP]
  • Manufacturer: NOVARTIS
    Approval date: June 17, 2011
    Strength(s): EQ 4MG BASE/100ML [RLD] [AP]

Has a generic version of Zometa been approved?

A generic version of Zometa has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Zometa and have been approved by the FDA:

zoledronic acid injectable;iv (infusion)

  • Manufacturer: ACS DOBFAR INFO SA
    Approval date: August 2, 2013
    Strength(s): EQ 4MG BASE/100ML [AP]
  • Manufacturer: ACTAVIS INC
    Approval date: March 4, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: AGILA SPECLTS
    Approval date: March 4, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: March 4, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: EMCURE PHARMS LTD
    Approval date: March 12, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: GLAND PHARMA LTD
    Approval date: August 5, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: HIKMA FARMACEUTICA
    Approval date: June 3, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: PHARMACEUTICS
    Approval date: March 4, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: PHARMS
    Approval date: May 7, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: March 4, 2013
    Strength(s): EQ 4MG BASE/5ML [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zometa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Pharmaceutical products comprising bisphosphonates
    Patent 7,932,241
    Issued: April 26, 2011
    Inventor(s): Glausch; Alexandra & Löffler; Rolf & Sigg; Juergen
    Assignee(s): Novartis AG
    A pharmaceutical product comprises a container containing a bisphosphonate solution, in which at least the internal surface of the container comprises a plastic material and in which the container is heat sterilisable, and which is in the form of a ready to use infusion solution, for administration of the bisphosphonate to a patient in need of bisphosphonate treatment.
    Patent expiration dates:
    • February 5, 2028
      ✓ 
      Drug product
  • Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases
    Patent 8,324,189
    Issued: December 4, 2012
    Inventor(s): Galli; Bruno & Schran; Horst F & Seaman; John J
    Assignee(s): Novartis Pharmaceuticals Corporation
    A method of intravenously administering a bisphosphonate to a patient in need of bisphosphonate treatment comprising intravenously administering 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid (zoledronic acid) or a pharmaceutically acceptable salt thereof over a period of 15 minutes to a patient in need of said treatment.
    Patent expiration dates:
    • May 29, 2025
      ✓ 
      Patent use: BONE METASTASES
    • May 29, 2025
      ✓ 
      Patent use: MULTIPLE MYELOMA
    • May 29, 2025
      ✓ 
      Patent use: HYPERCALCEMIA OF MALIGNANCY
    • November 29, 2025
      ✓ 
      Pediatric exclusivity

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

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